The FDA halts clinical trials of selinexor in CLL and DLBCL

The trials have been halted by the FDA due to incomplete information in the Investigator’s Brochure (IB), which includes an incomplete list of Serious Adverse Events (SAEs) associated with selinexor. This partial clinical hold placed by the FDA prevents new patients to be enrolled into clinical trials with selinexor. However, patients with stable disease or better may remain on selinexor therapy. So far, nearly 2,000 patients have been treated with selinexor.

Consequently, at the FDA’s request, Karyopharm, the drug’s manufacturers, have amended the IB and the informed consent documents accordingly. The updated documents were submitted to the FDA on 10th March 2017.

Currently, selinexor is being evaluated in multiple studies in R/R patients with B-cell lymphoma, in particular aggressive DLBCL and CLL.

One such trial which has been suspended is a phase I trial (NCT02303392) investigating selinexor combined with ibrutinib for the treatment of R/R CLL/SLL and aggressive NHLs including MCL and DLBCL. Additionally, results of the SADAL trial (NCT02227251) comparing high and low doses of selinexor in R/R DLBCL patients are highly anticipated.

Related articles

Apr 6, 2017

Professional society

The European Lymphoma Institute is comprised of a network of top European specialists in the field of lymphoma who are dedicated to research, training and education. Together they look to define strategies to analyse and characterize lymphoma and its common diagnostic procedures and therapeutic standards, as well as to facilitate clinical and fundamental research. This all results in the advancement of lymphoma research and it guarantees equal access for all patients to the best possible care.